Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2017 |
| Start Date: | October 2011 |
| End Date: | December 2016 |
This study will evaluate the effectiveness of an individualized approach to diagnosing and/or
treating atherosclerosis. This will be done by combining genetic information, lifestyle
information, participant education, and imaging tests to track diagnoses, therapies, and
treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to
standard of care) and 2) Individualized Management Group (standard of care plus genetic
testing and coronary artery calcium scans).
treating atherosclerosis. This will be done by combining genetic information, lifestyle
information, participant education, and imaging tests to track diagnoses, therapies, and
treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to
standard of care) and 2) Individualized Management Group (standard of care plus genetic
testing and coronary artery calcium scans).
The purpose of this proposal is to create a large, community-based demonstration project to
evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In
this project we set out to compare the delivery of appropriate therapies and resource
utilization using current national guidelines for the management of atherosclerosis and will
compare this to using a highly individualized approach for atherosclerosis risk reduction,
based on the evaluation of specific features in individuals and tailoring management based on
this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive
appropriate diagnoses and subsequent therapies in a more efficient manner.
evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In
this project we set out to compare the delivery of appropriate therapies and resource
utilization using current national guidelines for the management of atherosclerosis and will
compare this to using a highly individualized approach for atherosclerosis risk reduction,
based on the evaluation of specific features in individuals and tailoring management based on
this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive
appropriate diagnoses and subsequent therapies in a more efficient manner.
Inclusion Criteria:
- No known coronary artery disease
- no prior coronary disease by cardiac catheterization (≤39% in any major
epicardial vessel)
- no prior myocardial infarction
- no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous
leads)
- no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated
troponin that is indicative of myocardial necrosis based on local institutional
cutpoints)
- no prior coronary revascularization procedure
- Intermediate or high Framingham Risk Score (10-year risk 10% or greater)
- Ability and willingness to provide consent and Authorization for use of PHI
Exclusion Criteria:
- Presence of known cardiomyopathy
- Presence of permanent pacemaker, defibrillator, or CRT device
- Presence of clinically significant, uncontrolled arrhythmia (chronic or paroxysmal
atrial fibrillation is NOT an exclusion. Arrhythmias treated successfully with
ablation are not an exclusion.
- Presence of a known genetic abnormality of cholesterol metabolism (e.g. familial
hypercholesterolemia)
- Inability or unwillingness to adhere to follow up schedule
- Inability or unwillingness to provide informed consent and Authorization for use of
PHI
We found this trial at
1
site
Atlanta, Georgia 30309
Principal Investigator: Joseph Miller, MD
Phone: 404-605-2875
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